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510(k) Data Aggregation
K Number
K231365Device Name
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
Manufacturer
Anhui Intco Medical Products Co., Ltd
Date Cleared
2024-03-01
(295 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Intco Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|-----------------------------------------|-----------------------------------------------|
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.
Warning: Do not use with Carmustine or Thiotepa
| Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times |
|-----------------------------------------|--------------------------------------|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
Device Description
The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- Blue colored
- Containing Hyaluronic Acid coating.
- Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
- Tested against chemotherapy drugs and fentanyl citrate.
The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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K Number
K233598Device Name
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Manufacturer
Anhui Intco Medical Products Co., Ltd.
Date Cleared
2024-01-26
(78 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Intco Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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